TRU-TRAX— 510(k) K894851

Substantially Equivalent

Humagen, Inc.

FDA 510(k) clearance K894851 for TRU-TRAX, Substantially Equivalent on 1989-09-29. Applicant: Humagen, Inc.. Device class: 1.

Clearance details

Applicant: Humagen, Inc.
Product code: Code GIO
Device class: Class 1
Regulation: 21 CFR 864.6150
Advisory panel: Hematology
Date received: 1989-07-31
Decision date: 1989-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottesville, VA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.